Treatment of Hyperhidrosis With Oxybutynin (H²O)
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|ClinicalTrials.gov Identifier: NCT01855256|
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : July 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hyperhidrosis||Drug: Oxybutynin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Treatment of Hyperhidrosis With Oxybutynin: a Randomized Controlled Double Blind Against Placebo|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||March 2014|
Oxybutynin was done at 2.5 mg/day from day 1 to day 4, then at 5 mg/day from day 5 to day 7 and at 7.5 mg/day from day 8 to the end of the 6 weeks.
Oxybutynin is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.
Placebo Comparator: Placebo
Placebo was done at 2.5 mg/day from day 1 to day 4, then at 5 mg/day from day 5 to day 7 and at 7.5 mg/day from day 8 to the end of the 6 weeks.
Placebo is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.
- Evaluation of the effectiveness of oxybutynin in hyperhidrosis [ Time Frame: 6 weeks ]Two scales are used for this evaluation (Hyperhydrosis Disease Severity Scale and Dermatology Life Quality Index )
- Safety evaluation of treatment in this indication [ Time Frame: 6 weeks ]Number of Participants with Adverse Events will be followed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855256
|Brest, France, 29609|
|Landerneau, France, 29800|
|CHG de Morlaix|
|Morlaix, France, 29600|
|Quimper, France, 29000|
|Principal Investigator:||Martine SCHOLLHAMMER, MD||ADBO|